14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRO-FLOW MULTIPURPOSE CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845327·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE EXTRA LA...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450363362·
POWER SUPPLY / BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code IYN·March 28, 2011
POWER SUPPLY/BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code ITX·July 30, 2010
POWER SUPPLY/BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code ITX·June 25, 2010
GRIP LOCK ANCHOR, MODEL 411374
FDA 510(k)
FDA Class 2
·Neurology
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
UNK
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MHY·May 23, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
FDA Adverse Event
Injury
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012